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 Department of Health and Human Services Food and Drug Administration [Docket No. 2004P-0262]
 AGENCY: Food and Drug Administration, HHS.
 ACTION: Notice.
 SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of 128 suitability petitions. This action is being taken in accordance with the Pediatric Research Equity Act of 2003 (PREA). Prior to PREA's enactment, FDA had approved these suitability petitions to permit abbreviated new drug applications (ANDAs) to be submitted for drugs that had a different active ingredient, dosage form, or route of administration than their reference listed drugs (RLDs). However, these approval decisions are being withdrawn because ANDAs were never submitted and PREA requires that all applications submitted on or after April 1, 1999, for a new active ingredient, new indication, new dosage form, new dosing regimen, or new route of administration contain an assessment of the safety and effectiveness of the drug for the claimed indications in relevant pediatric subpopulations unless the requirement is waived or deferred. This action is being taken without prejudice. Any of the suitability petitions may be resubmitted for action by the agency in accordance with current law.
 DATES: This notice is effective March 26, 2007.
 FOR FURTHER INFORMATION CONTACT: Cecelia M. Parise, Center for Drug Evaluation and Research (HFD-600), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-5845.


SUPPLEMENTARY INFORMATION: PREA (Public Law 108-155) was enacted on December 3, 2003. Among other things, section 2 of PREA requires that all drug applications submitted on or after April 1, 1999, for a new active ingredient, new indication, new dosage form, new dosing regimen, or new route of administration contain an assessment of the safety and effectiveness of the drug for the claimed indications in relevant pediatric subpopulations unless the requirement is waived or deferred. As a result, FDA is withdrawing its approval for 128 suitability petitions for which ANDAS were never submitted. The approval decisions, made prior to the enactment of PREA, would have permitted ANDAs to be submitted for certain drugs that have a different active ingredient, dosage form, or route of administration than their RLDs. No ANDAs were submitted for these drugs pursuant to these suitability petitions prior to April 1, 1999, and any such application submitted on or after April 1, 1999, would be required to contain the safety and effectiveness assessments required by PREA, unless waived or deferred. According to § 314.93(e)(1)(i) (21 CFR 314.93(e)(1)(i)), a suitability petition may not be approved if investigations must be conducted to show the safety and effectiveness of the drug product. In addition, according to § 314.93(f), FDA may withdraw approval of a suitability petition if it receives information demonstrating that the petition no longer satisfies the conditions of § 314.93(e). Under PREA, safety and effectiveness investigations in pediatric subpopulations would be required for the drug products proposed by these suitability petitions, unless the requirement is waived or deferred. Therefore, these suitability petitions no longer satisfy the regulatory requirements for approval. Pursuant to § 314.93(f), FDA is withdrawing approval of the 128 suitability petitions listed in the following table: Petition No.
Drug
Petitioner82N-0032/CP6
Chlorzoxazone 500 milligrams (mg)
Mikart, Inc.84N-0116/CP1
Disopyramide Phosphate 200 mg or 300 mg
Biocraft Laboratories, Inc.84P-0228/CP1
Acetaminophen 500 mg,
                             Codeine Phosphate 30 mg or 60 mg
McNeil Pharmaceutical85P-0067/CP1
Methyltestosterone 25 mg
Star Pharmaceuticals85P-0074/CP1
Hydralazine Hydrochloride 25 mg/5 milliliters (mL)
Roxane Laboratories, Inc.85P-0081/CP1
Flurazepam Hydrochloride 30 mg/mL
Do.85P-0084/CP1
Vincristine Sulfate 2 mg
Bristol Laboratories( print page 8185)85P-0091/CP1
Flurazepam Hydrochloride 15 mg/5 mL
Roxane Laboratories, Inc.85P-0095/CP1
Brompheniramine Maleate 12 mg,
                             Pseudoephedrine Hydrochloride 120 mg
UAD Laboratories, Inc.85P-0129/CP1
Propranolol Hydrochloride 160 mg
Verex Laboratories, Inc.85P-0140/CP1
Dexbrompheniramine Maleate 6 mg,
                             Pseudoephedrine Hydrochloride 120 mg
Central Pharmaceuticals, Inc.85P-0140/CP2
Dexbrompheniramine Maleate 6 mg,
                             Pseudoephedrine Sulfate 120 mg
Do.85P-0147/CP1
Ketoconazole 20 mg/mL
Janssen Pharmaceutica85P-0197/CP1
Propranolol Hydrochloride 80 mg, 120 mg, 160 mg
Forest Laboratories85P-0215/CP1
Disulfiram 500 mg/30 mL
Paddock Laboratories85P-0238/CP2
Dexbrompheniramine Maleate 6 mg,
                             Phenylpropanolamine Hydrochloride 75 mg
Bock Pharmacal Co.85P-0269/CP1
Codeine Phosphate 10 mg/5 mL,
                             Dexbrompheniramine Maleate 1 mg/5 mL, 
                             Phenylpropanolamine Hydrochloride 12.5 mg/5 mL
Do.85P-0423/CP1
Benztropine Mesylate 0.5 mg/5 mL
RIM Consulting Corp.85P-0492/CP1
Azatadine Maleate 1 mg,
                             Phenylpropanolamine Hydrochloride 75 mg
Smith, Kline & French Laboratories85P-0499/CP1
Diazepam 2 mg/5 mL
Carolina Medical Products Co.85P-0510/CP1
Spironolactone 25 mg/5 mL
Do.85P-0515/CP1
Lorazepam 0.5 mg, 1 mg, or 2 mg
Wyeth Laboratories, Inc.85P-0516/CP1
Oxazepam 15 mg or 30 mg
Do.85P-0543/CP1
Acetaminophen 300 mg,
                             Codeine Phosphate 30 mg
Softan, Inc.85P-0543/CP2
Acetaminophen 500 mg,
                             Codeine Phosphate 7.5 or 15 mg
Do.85P-0543/CP3
Acetaminophen 500 mg,
                             Oxycodone Hydrochloride 5 mg
Do.85P-0563/CP1
Ibuprofen 300, 400, or 600 mg
Do.85P-0581/CP1
Acetaminophen 500 mg,
                             Propoxyphene Hydrochloride 32 mg
Do.86P-0045/CP1
Propranolol Hydrochloride 10, 20, 40, 60, 80, 90 mg
Nutripharm, Inc.86P-0055/CP1
Spironolactone 25 mg/5 mL
Carolina Medical Products Co.86P-0123/CP1
Cholestyramine 4 grams (g)
Parke-Davis, Division of Warner-Lambert Co.86P-0200/CP1
Acetaminophen 650 mg,
                             Codeine Phosphate 15 mg
Mikart, Inc.86P-0242/CP1
Floxuridine 500 mg/5 mL
Quad Pharmaceuticals, Inc.86P-0292/CP1
Lorazepam 1 mg/5 mL
Roxane Laboratories, Inc.86P-0359/CP1
Aspirin 356.4 mg,
                             Caffeine 30 mg, 
                             Dihydrocodeine Bitartrate 16 mg
Central Pharmaceuticals, Inc.86P-0361/CP1
Acetaminophen 325 mg,
                             Aspirin 325 mg, 
                             Codeine Phosphate 30 mg
Bock Pharmacal Co.( print page 8186)86P-0427/CP1
Hydrochlorothiazide 50 mg,
                             Triamterene 75 mg
Par Pharmaceutical, Inc.86P-0474/CP1
Cholestyramine 500 mg
Bristol-Myers Squibb87P-0004/CP1
Fluocinonide 0.05%
Richard Hamer Assoc.87P-0037/CP1
Lorazepam 0.5 mg, 1 mg, 2 mg
Applied Laboratories, Inc.87P-0101/CP1
Verapamil Hydrochloride 40 mg/5 mL or 80 mg/5 mL
MY-K Laboratories, Inc.87P-0233/CP1
Verapamil Hydrochloride 120 mg or 240 mg
Searle Research & Development87P-0242/CP1
Ibuprofen 800 mg
Sidmak Laboratories, Inc.87P-0265/CP1
Dexbrompheniramine Maleate 6 mg,
                             Phenypropanolamine Hydrochloride 75 mg
Bock Pharmacal Co. (King & Spalding)87P-0268/CP1
Loperamide Hydrochloride 2 mg
Kross, Inc.87P-0301/CP1
Cholestyramine Resin 4 g
Ciba-Geigy Corp.87P-0314/CP1
Clemastine Fumarate 1.34 mg,
                             Pseudoephedrine Hydrochloride 120 mg
Sandoz Consumer Healthcare Group87P-0323/CP1
Acetaminophen 160 mg/5 mL,
                             Codeine Phosphate 6 mg/5 mL
Kleinfeld, Kaplan & Becker87P-0335/CP1
Triamterene 50 mg,
                             Hydrochlorothiazide 25 mg
Par Pharmaceutical, Inc.87P-0340/CP1
Nifedipine 10 mg or 20 mg
Do.87P-0367/CP1
Phenytoin Sodium 100 mg, 250 mg/vial
Lyphomed, Inc.87P-0399/CP1
Propranolol Hydrochloride 40 mg or 80 mg/5 mL,
                             Hydrochlorothiazide 25 mg/5 mL
Burditt, Bowles, Radzius & Rudberry88P-0011/CP1
Cyclophosphamide 20 mg/mL, 500 mL pharmacy bulk pack (PBP)
Baxter Healthcare Corp.88P-0036/CP1
Chlorhexidine Gluconate 0.5%
Arent, Fox, Kinter, Plotkin & Kahn88P-0061/CP1
Homatropine Methylbromide 1.5 mg,
                             Hydrocodone Bitartrate 5 mg
Kleinfeld, Kaplan & Becker88P-0149/CP1
Leucovorin Calcium 1 mg/mL
Roxane Laboratories, Inc.88P-0277/CP1
Quinidine Sulfate 300 mg
A. H. Robins88P-0350/CP1
Clemastine Fumarate 1.34 mg,
                             Phenylpropanolamine Hydrochloride 75 mg
Scientific Consulting of VA, Inc.88P-0379/CP1
Cyclophosphamide 20 mg/mL, 250 mL PBP
Baxter Healthcare Corp.88P-0391/CP1
Prednisone 1 mg, 2.5 mg, 5 mg, 10 mg, 20 mg, 25 mg, or 50 mg
B.F. Ascher & Co., Inc.89P-0028/CP1
Hydrocortisone Valerate 0.2%
McKenna, Conner & Cuneo89P-0029/CP1
Hydrocortisone Valerate 0.2%
Do.89P-0071/CP1
Morphine Sulfate 30 mg
Ethypharm/Oxford Research Intl. Corp.89P-0399/CP1
Carbamazepine 200 mg/5 mL
Guidelines, Inc.89P-0435/CP1
Pentamidine Isethionate 100 mg/mL
Astra Pharmaceutical Products, Inc.90P-0049/CP1
Hydrocortisone Acetate 2.5% or 1%
Ferndale Laboratories, Inc.90P-0084/CP1
Chlorzoxazone 250 mg
Mikart, Inc.90P-0154/CP1
Hydrocortisone Acetate 1%
Ferndale Laboratories, Inc.90P-0198/CP1
Clobetasol Propionate 0.05%,
                             RLD = Temovate
Kross, Inc.( print page 8187)90P-0436/CP1
Nifedipine 30 mg, 60 mg, 90 mg
KV Pharmaceutical Co.91P-0348/CP1
Albuterol Sulfate 4 mg
Richard Hamer Associates, Inc.92P-0048/CP2
Triazolam 0.125 mg/5 mL
Roxane Laboratories, Inc.92P-0101/CP1
Hydrocortisone Acetate 2.5%
Hogan & Hartson92P-0282/CP1
Acetaminophen 150 mg,
                             Aspirin 180 mg, 
                             Hydrocodone Bitartrate 5 mg
Mikart, Inc.92P-0282/CP2
Acetaminophen 150 mg,
                             Aspirin 180 mg, 
                             Hydrocodone Bitartrate 7.5 mg
Do.92P-0282/CP3
Acetaminophen 150 mg,
                             Aspirin 180 mg, 
                             Hydrocodone Bitartrate 2.5 mg
Do.92P-0282/CP4
Acetaminophen 150 mg,
                             Aspirin 180 mg, 
                             Hydrocodone Bitartrate 10 mg
Do.92P-0332/CP1
Propranolol Hydrochloride 40 mg
Flemington Pharmaceutical Corp.92P-0335/CP1
Albuterol Sulfate 2 mg, 4 mg
WE Pharmaceuticals, Inc.92P-0336/CP1
Prednisone 5 mg or 10 mg
Do.92P-0381/CP1
Cytarabine 20 mg/mL, 12.5 mL
Bristol-Myers Squibb Co.92P-0500/CP1
Timethoprim 25 mg/5 mL
Ascent Pharmaceuticals, Inc.93P-0048/CP1
Cimetidine 200, 300, 400 or 800 mg
Flemington Pharmaceuticals Corp.93P-0049/CP1
Propranolol Hydrochloride 10, 20, 60, 80, 90 mg
Do.93P-0314/CP1
Acetaminophen 500 mg,
                             Codeine Phosphate 45 mg
Mikart, Inc.93P-0332/CP1
Loperamide Hydrochloride 1 mg
Asta Medica GmbH93P-0333/CP1
Prednisone 1, 2.5, 20, 50 mg
Dura Pharmaceuticals93P-0346/CP1
Acetaminophen 325 mg,
                             Butalbital 50 mg, 
                             Caffeine 40 mg, 
                             Hydrocodone Bitartrate 5 mg
Mikart, Inc.93P-0367/CP1
Terfenadine 60 mg,
                             Pseudoephedrine 120 mg
Eurand America93P-0446/CP1
Morphine Sulfate 15 mg, 60 mg, 90 mg, 100 mg
Ethypharm93P-0459/CP1
Methyltestosterone 25 mg
ICN Pharmaceuticals, Inc.94P-0182/CP1
Acetaminophen 120 mg,
                             Codeine Phosphate 12 mg
WE Pharmaceuticals, Inc.94P-0186/CP1
Sulfamethoxazole 200 mg,
                             Trimethoprim 40 mg
Dura Pharmaceuticals94P-0199/CP1
Lorazepam 1 mg/10 mL
Roxane Laboratories, Inc.94P-0210/CP1
Acetaminophen 150 mg,
                             Aspirin 180 mg, 
                             Codeine Phosphate 60 mg
Mikart, Inc.94P-0211/CP1
Acetaminophen 150 mg,
                             Aspirin 180 mg, 
                             Codeine Phosphate 30 mg
Do.( print page 8188)94P-0212/CP1
Acetaminophen 150 mg,
                             Aspirin 180 mg, 
                             Codeine Phosphate 15 mg
Do.94P-0263/CP1
Fluorouracil 5%
Bradley Pharmaceuticals, Inc.94P-0432/CP1
Methylprednisolone 16 mg, 24 mg, 32 mg
Dura Pharmaceuticals94P-0433/CP1
Leucovorin Calcium 10 mg/mL 350 mg vial
Lederle Laboratories94P-0433/CP2
Leucovorin Calcium 10 mg/mL 5 mL vial
Do.95P-0008/CP1
Captopril 25 mg/mL
Roxane Laboratories, Inc.95P-0100/CP1
Carbidopa/Levodopa 25/100 mg, 25/250 mg
Athena Neurosciences, Inc.95P-0223/CP1
Hydrocortisone Butyrate 0.1%
McKenna & Cuneo, L.L.P.95P-0268/CP1
Acyclovir Sodium 5 mg/mL
Wilmer, Cutler, Pickering95P-0277/CP1
Cholestyramine 2 g
Mayrand Pharmaceuticals, Inc.95P-0279/CP1
Butalbital 50 mg,
                             Acetaminophen 325 mg, 
                             Caffeine 40 mg, 
                             Hydrocodone Bitartrate 10 mg
Mikart, Inc.95P-0279/CP2
Butalbital 50 mg,
                             Acetaminophen 325 mg, 
                             Caffeine 40 mg, 
                             Hydrocodone Bitartrate 7.5 mg
Do.95P-0279/CP3
Butalbital 50 mg,
                             Acetaminophen 500 mg, 
                             Caffeine 40 mg, 
                             Hydrocodone Bitartrate 10 mg
Do.95P-0279/CP4
Butalbital 50 mg,
                             Acetaminophen 500 mg, 
                             Caffeine 40 mg, 
                             Hydrocodone Bitartrate 7.5 mg
Do.95P-0326/CP1
Nifedipine 30 mg, 60 mg, 90 mg
KV Pharmaceutical Co.95P-0328/CP1
Metronidazole 0.75%
RNB Pharmaceutical Co.96P-0018/CP1
Potassium Chloride 20 milliequivalents (meq)
KV Pharmaceutical Co.96P-0021/CP1
Aspirin 650 mg
                             Butalbital 50 mg
Savage Laboratories, Division of Altana, Inc.96P-0054/CP1
Potassium Chloride 10 meq
KV Pharmaceutical Co.96P-0079/CP1
Pentoxyfylline 400 mg
Do.96P-0307/CP1
Acyclovir 5%
Pitney, Hardin, Kipp & Szuch96P-0376/CP1
Hydrocortisone Acetate 90 mg
Do.96P-0510/CP1
Diltiazem Hydrochloride 120 mg, 180 mg, 240 mg,
                             RLD = Cardiazem CD
Labopharm, Inc.97P-0155/CP1
Mefenamic Acid 250 mg
Pitney, Hardin, Kipp & Szuch97P-0192/CP1
Diltiazem Hydrochloride 120 mg, 180 mg, 240 mg,
                             RLD = Dilacor XR
Labopharm, Inc.97P-0195/CP1
Diltiazem Hydrochloride 120 mg, 180 mg, 240 mg,
                             RLD = Tiazac
Do.97P-0387/CP1
Albuterol Sulfate 2 mg and 4 mg
Richard Hamer Assoc., Inc.97P-0404/CP1
Famotidine 10 mg
Thomas Blake, R.Ph.( print page 8189)98P-0068/CP1
Clobetasol Propionate 0.05%,
                             RLD = Temovate E
Richard Hamer Associates, Inc.98P-0146/CP1
Ifosfamide 50 mg/mL, 20 mL, and 60 mL
Mitchall G. Clark98P-0199/CP1
Captopril 25 mg/5 mL
Miran Consulting, Inc.98P-0745/CP1
Econazole Nitrate 1%
Do.
 This action is being taken without prejudice. Any of these petitions may be resubmitted for action by the agency in accordance with current law. Dated: February 13, 2007. Jeffrey Shuren, Assistant Commissioner for Policy.


[FR Doc. E7-3043 Filed 2-22-07; 8:45 am] BILLING CODE 4160-01-S